BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSENTIO MRI DR

    MDR report key: 24885074 · Received April 15, 2026

    Report

    Report Number
    2124215-2026-20294
    Event Type
    Injury
    Date Received
    April 15, 2026
    Date of Event
    April 3, 2026
    Report Date
    April 15, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526558979
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WITH THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDED THE CLINICAL OBSERVATION OF BRADY PACING RATE NOT AS EXPECTED IS A KNOWN INHERENT RISK OF THE DEVICE AND IS NOTED WITHIN THE DEVICE INSTRUCTIONS FOR USE (IFU), AS WELL AS THE PRODUCT'S RISK DOCUMENTATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF BRADY PACING RATE NOT AS EXPECTED WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. REVIEW OF LABELING DETERMINED THAT THE COMPLAINT SITUATION WAS LISTED IN THE MANUAL. THERE WAS NO INDICATION IN THE COMPLAINT THAT THE PRODUCT WAS NOT USED IN ACCORDANCE TO LABELING. THE MANUAL WAS UNLIKELY TO BE THE CAUSE OF THE REPORTED COMPLAINT; TRANSLATION, WORDING, OR GRAPHICS DOES NOT REQUIRE FURTHER REVIEW. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER DEVICE EXHIBITED HIGH PREMATURE VENTRICULAR CONTRACTION (PVC) BURDEN WHICH WAS SUSPECTED TO BE ATRIAL DRIVEN. THE PATIENT HAD FREQUENT PVCS AND USED TO TAKE MEDICATION. THE PATIENT REPORTED SYMPTOMS OF FATIGUE, UNSTEADINESS ON FEET AND CHEST PAIN. PROGRAMMING WAS PERFORMED BY TURNING POST-VENTRICULAR ATRIAL REFRACTORY PERIOD (PVARP) AFTER PVC OFF TEMPORARILY, HOWEVER THERE WAS NO CHANGE. TECHNICAL SERVICES (TS) REVIEWED AND STATED THAT A SIMPLE INCREASE OF LRL OR MAKING SENSOR RESPONSE MORE AGGRESSIVE MAY SUPPRESS BIGEMINIES AND PVCS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER DEVICE EXHIBITED HIGH PREMATURE VENTRICULAR CONTRACTION (PVC) BURDEN WHICH WAS SUSPECTED TO BE ATRIAL DRIVEN. THE PATIENT HAD FREQUENT PVCS AND USED TO TAKE MEDICATION. THE PATIENT REPORTED SYMPTOMS OF FATIGUE, UNSTEADINESS ON FEET AND CHEST PAIN. PROGRAMMING WAS PERFORMED BY TURNING POST-VENTRICULAR ATRIAL REFRACTORY PERIOD (PVARP) AFTER PVC OFF TEMPORARILY, HOWEVER THERE WAS NO CHANGE. TECHNICAL SERVICES (TS) REVIEWED AND STATED THAT A SIMPLE INCREASE OF LRL OR MAKING SENSOR RESPONSE MORE AGGRESSIVE MAY SUPPRESS BIGEMINIES AND PVCS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947572 ESSENTIO MRI DR PACEMAKERS LWP BOSTON SCIENTIFIC CORPORATION L111 913984 00802526558979

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Other